1. Field of the Invention
The present invention generally relates to urine specimen collecting means and more particularly to an improved disposable device for effectively, inexpensively and sterilely collecting the mid-stream portion of urine from a patient.
2. Description of the Prior Art
Urine analysis is such a simple, common and useful diagnostic aid that the taking of a urine specimen is generally included in even the simplest of physical examinations. It is important not only as an indicator or detector of certain physical conditions and diseases, but it is also particularly useful in connection with the treatment of infections related to the urinary tract, which are much more common in females than males. However, the problem of collecting a suitable specimen is considerably more complex when a female patient is involved.
Thus, in the collecting of a urine specimen from a female patient, it is important to take the specimen as a "mid-stream" sample. When a female patient voids in the normal manner, the initial portion is more likely to contain contamination from foreign matter than that portion which follows. This is because the initial portion is expelled with less force and usually is voided as a mere trickle which is likely to trail along the labia and pick up whatever contamination is present in those areas. The mid-stream portion is expelled with the greatest force and is most likely to leave the urethral meatus directly as a stream without contacting the labia or, if it does, the labia will have had most of the contamination washed off by the initial portion.
Some practitioners go to considerable lengths in an effort to obtain an uncontaminated urine sample from a female patient. With the patient in a reclining position, an attendant cleanses the area adjacent the urethral meatus with a suitable solution in an effort to wash off the contamination which is generally present in that area. Even with such precautions, however, contamination may develop in the collected urine sample to a level sufficient to give a false or misleading indication of the bacteria level in the sample. Moreover, taking a sample under such conditions is an extremely awkward and uncomfortable experience for the patient and is fairly costly, since the patient is required to be present in the physician's office or a hospital with a special attendant, usually a nurse, administering the procedure.
One conventional device for self administration employs a jar with screw collar and handle, plastic cover and screw cap and three cleansing towels. The cap must first be removed, then the towels are used to cleanse the urethral meatus, etc., after which the user voids an initial portion of urine into a toilet and then catches the mid-stream portion in the jar. The whole procedure is complicated and time-consuming with relatively poor results due to the contamination of a significant proportion of samples taken by this procedure.
What is needed is some simple but effective, fool-proof device, preferably disposable after a single use, which a patient can use with a minimum of instructions and without assistance, while voiding in the normal manner. The device should have the capability of receiving the entire amount of voided urine, rejecting the initial portion, selecting a portion corresponding to the mid-stream sample and transferring it to a specimen container, and rejecting the remainder of the voided urine by directing it, together with any overflow from the specimen container, into the toilet on which the patient is positioned in the normal attitude.
Although the device set forth in U.S. Pat. No. 4,040,791 for Specimen Collecting Device accomplishes the foregoing objects, such device has been found to be somewhat complicated and expensive to manufacture. For example, it cannot be made in a single high-speed molding operation but must be assembled from a plurality of parts. Morever, it requires certain close tolerances which demand high quality control. Therefore it is not as simple and inexpensive as one would desire for a disposable device intended for extensive usage. Moreover, it is somewhat difficult to handle and orient while using. Therefore, it would be desirable to provide an improved device of the same general type which would be as efficient but less expensive, and easier to handle, orient and use.
The urine collection devices described and claimed in U.S. Pat. Nos. 4,252,132, 4,276,889 and 4,331,162 offer certain advantages over the device of U.S. Pat. No. 4,040,791, but are nevertheless still relatively expensive, so that they are not ideally suitable for use in large scale examinations in free clinics and the like, where cost is of prime importance. Certain of such devices are also relatively bulky, taking up considerable storage space. Accordingly, the need still exists for a very simple, easy to use, very low cost, small, disposable urine collector suitable for use by both males and females.